International Catholic University
The preceding lecture concluded with a consideration of the safety issue of cloning based on animal experimentation. This lecture will take up the remaining questions: the concordance of the procedure with norms governing experimentation on human subjects; the potential harms and injustices to prospective human offspring; potential harms and injustices to women; potential harms and injustices to families; potential harms and injustices to society; violation of religious principles.
The issue of the concordance of the procedure with ethical codes for governing human experimentation is not unproblematic. Two international codes, the Nuremberg Code (1946) and the Helsinki Declaration (1964), as well as U.S. codes, the Belmont Report (1978), published by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, and the Code of Federal Regulations, are pertinent to the issue of cloning-to-produce-children. Each of these codes centers on the value of human dignity and the limits of research. And all prohibit experimentation that is dangerous to human beings. The Nuremberg Code requires, in article 1, the informed consent of the research subject, in article 2 that the experiment provide a concrete good for society unavailable by any other means, in article 3 that animal research precede research on human subjects, and in articles 4, 5, 6, and 7 that the subject be protected from harm. The Declaration of Helsinki, which advances on the Nuremberg Code by making a distinction between research directed to the medical care of patients and medical research for the advancement of knowledge, has many of the same requirements as the Nuremberg Code, that is, that the subject be informed and that the benefits clearly outweigh the risks. Important advances enumerated in the Helsinki Declaration are the following. In medical research on human subjects, considerations related to the well-being of the human subject should take precedence over the interests of science and society; special provisions are to be made for those who cannot give consent; and in the case where consent cannot be directly attained that the research benefit be specific to the research-subject population. The Belmont Report continues many of the same protections and distinguishes between ethical principles that guide research into medical care and ethical principles that guide experimental research. The Report lists as guiding the principles of respect for persons, beneficence, and justice. The constellation of these principles requires respect for the autonomy and rights of persons and special protection for persons with diminished capacity, that the scientific research be beneficial, in a concrete and meaningful way, either to the individuals involved in the research or to others, and that the harms and benefits be distributed justly and that the research subjects be selected fairly. The most recent regulations governing research in the United States are found in the Code of Federal Regulations. These regulations hold that research involving those who are incompetent requires assent of the participant as well as consent of the person who has legal authority over the participant.
In summary, all four codes have consent provisions, protection from harm requirements, all four require some benefit calculation, and all four have directions for the selection of subjects. The Belmont Report appears to have the broadest requirement for subject selectivity and for benefit, that is benefit is not limited to the individual subject or to any particularity about the subject research group, but is directed to society as a whole. In the application of the central requirements of these codes to cloning-to-produce-children, there is concern for the informed consent of the adult participants in the process but the assent provision, which would be impossible to get, is simply ignored. There is little concern expressed for the new human being to be generated. This disregard has its source in the myopia generated by the contemporary lack of legal status for the unborn but conceived human being. At a minimum a best interests standard would be required to be invoked. It is evident that the strict application of the restrictions of these codes would prohibit cloning-to-produce-children and cloning-for-biomedical-research.
The potential harms to prospective human cloned offspring are physical as well as psychological and social. The potential physical harms to cloned children, extrapolating from the real harms experienced by cloned animals, include a greater than normal risk of dying before birth, fatal abnormalities that cause death shortly after birth or after a relatively short life span, and non-fatal abnormalities such as "increased birth size, liver and brain defects, and lung, kidney, and cardiovascular problems" (NAS Report, chapter 3). Some short-term consequences observed in cloned animals include failure of the immune system, premature aging, and sudden death. Long-term consequences in cloned animals are simply unavailable, so no hypotheses about the long-term effects of cloning-to-produce-children are possible.
Among the possible psychological and social concerns for a cloned child are the following. The cloned individual would inherit a genetic identity already lived (in the case that the source of the somatic cell is someone who died) or would inherit a genetic identity that is being lived by another (in the case that the source of the somatic cell is a contemporaneously living human being) or would inherit a particular genetic identity chosen by someone else (in the case that designer genes were selected or genes were manipulated). The first might cause of problem of expectations, for example, if the intention of the cloning were to produce a virtuoso violinist or an exceptionally gifted athlete or a brilliant scientist or a raving beauty, the offspring might experience unbearable pressure to live up to those expectations or suffer overwhelming guilt if other interests, self-chosen interests, became more directing of one's life. The second might cause a problem of familial relationship. If one parent is the source of the somatic cell, then the offspring has genetic linkage to only one parent. Furthermore, the relationship to the human being who is the source of the cell becomes complicated, that is, is the relationship that of twin siblings or that of parent/child. The third possibility, if the somatic cell is taken from someone outside the biological family, the cloned child would not have biological ties to the rearing family. (While this might be considered similar to adoption, there are two concerns: adoption is, in a sense a rescue act and the clone in this instance represents the deliberate choice to bring a human being into existence in a particular set of circumstances and, furthermore, adoption itself has some obstacles to be overcome by the lack of biological relationship.) A fourth possibility suffers the risk of cloned human being's being treated like any other consumer good or object of a parent's aspirations. Leon Kass cautions that "[p]arental control is a double-edged sword" which may be the source of psychological and physical harms for "the child whose genetic identity is selected in advance" (PCR, 94). Children have an identity independent of parent's desires and children ought to be understood as entitled to lives that are independent of their parents.
There are potential harms and injustices to women latent in the press for cloning-to-produce-children. The DNA of the somatic cell must be fused into an oocyte -- a human egg cell -- and there must be a womb to carry the newly conceived human being to term. All present cloning techniques require large numbers of oocytes. Recall that the production of one sheep, Dolly, required two hundred and seventy-seven sheep eggs. If a woman, on average, produces twelve or thirteen mature eggs each year in her fertile years, it would take at least twenty years to produce eggs sufficient to produce one live birth, if extrapolation from the Dolly scenario were possible and if cloning-to-produce-children were no more complicated than cloning Dolly. Of course, science has not the time to wait twenty years and, of course, science has the technology to speed things up. Hormonal treatments are available to induce superovulation in women and surgical procedures are available to retrieve the eggs produced by superovulation. Hormonal treatments to induce superovulation have both physical and emotional risks for women and no surgical procedure is without anxiety. The exaggerated emotional highs and emotional lows subsequent to hormone therapy are well enough documented to have earned a name of their own -- the Bambi/Hitler syndrome. And since only women have wombs, there must be some woman who is willing and able to carry the newly generated human being to term. This then is a kind of surrogacy.
Because animal cloning results in dangers to the clone-bearing mother that are not insignificant, human cloning-to-produce-children cannot be permitted to go forward at this time and at this level of experimental competence. Animal cloning is accompanied by increased morbidity and mortality for the host mother. The NAS Report lists the following. "Increased maternal morbidity and mortality can result from late gestational fetal loss, increased size of the fetus, abnormal placentation, pregnancy toxemia, and most notably, hydroallantois and/or hydranminos (excessive fluid accumulation in the uterus often associated with fetal abnormality and maternal distress)" (NAS, 42).
There is considerable debate among some feminists as to whether these new procedures present new economic opportunities for women and, hence a unique good for women, or if the new procedures present a whole new set of burdens rooted in biological structures unique to women. If financial incentives were offered for egg production or for womb use it might be the case that only women in difficult economic circumstances might offer their bodily capacities for such projects. There are at least two risks here. The first risk is that the acceptance of this role has the potential to reduce poor women to objects of production. The second risk is that if women are choosing from the position of economic necessity rather than personal flourishing or gift giving, then the consent to the procedure, whether egg donation or womb use, loses its voluntary character. The real possibility of both of these risks is potential assault on the dignity of women. The potential harms and injustices to families and to society at large are, for the most part, not physical harms, but possible structural harms and injustices that might arise from a change in order in the family and in society. The potential harms to family include those or relationship and those of inheritance -- genetic as well as economic. Those of relationship have to do with the human dignity and human equality. The Report of the President's Council has this to say: "a begotten child comes into the world just as its parents once did, and is therefore their equal in dignity and humanity . . . [and] . . . our emergence from the union of two individuals, themselves conceived and generated as we were, locates us immediately in a network of relation and natural affection" (PCR, 112). Among the potential harms to society is the traversing of a major natural boundary in the transition from sexual to asexual cloning and the probable industrialization of human production with the likely attendant practices of the destruction of those determined unfit or imperfect.
The Catholic tradition, which is central to the treatment of medical issues in these lectures, holds as normative that children are a good -- gifts of God conceived in love born in faith of the goodness of human life and in the hope of everlasting life. It holds that (1) that children are to born of marriage; (2) that children are to born of the marriage act, marital intercourse which unites husband and wife in an act that is open to procreation; and (3) that while all human beings have intrinsic dignity that commands respect, vulnerable human beings -- "the least of these" -- are to be the recipients of special care. Most instances of cloning-to-produce-children would be violative of the first and all the instances of cloning-to-produce-children would be violative of the second. And cloning-to-produce-children which accepted as ordinary practice, the direct destruction of those deemed less than perfect violates the third. So the Catholic tradition has principles in places that exercise a limit on the practice of cloning-to-produce-children. To these principles are to be added the potential physical and psychological and sociological harms to children, to women, to families, and to society.
An important question: if the physical risks to the mother and the child are shown to be statistically acceptable, that is, the mortality rate of each equals the mortality rate of normal conception and child bearing and if the morbidity rate equals that associated with normal conception and child bearing, would cloning then become morally acceptable? Could the objections to potential harms, if the physical harms were overcome, to the cloned human being, the family, and society be overcome? Will those holding a particular religious tradition, such as committed Catholics, which proscribes cloning become an alien community in a culture that reduces progress to scientific progress, that values human beings designed to meet certain standards of acceptability, and that permits the early destruction of cloned human beings who do not meet such standards? If the tradition is the repository of truth, its alien status is to be endured -- as sign of commitment and in the hope of transformation. The tradition, however, must be mindful of its obligation to continue to study its tradition so that its understanding of the truth is a truthful understanding. In this, the tradition accepts the duty set forth by Pope Leo XIII in the encyclical AETERNI PATRIS "vetera novis augere et perficere" -- "to add to and perfect the old by the new" (Lonergan, 768).
The second set of moral issues centers on the question of cloning-for-biomedical-research. Here the issue is the production of the human embryo for purposes other than the well-being of the human embryo itself. The embryo is produced by way of somatic cell nuclear transfer and cultured to an appropriate stage after which either the study of its development commences or the stem cells from its inner cell mass are harvested for use in treatment in either regenerative medicine or in transplantation medicine.
The use of stem cells has captured the imagination of scientists and the sympathies of the general public. The reason for this lies in the possible use of stem cells for increase in scientific knowledge and the possible therapeutic use of stem cells in regenerative medicine. It is important to note that, at the present stage of scientific and medical knowledge, such "possible" use of stem cells is largely promise. Now those ends -- knowledge and therapy -- are good ends. So what's the fuss? What lies at the heart of the fuss is the use of embryonic stem cells. So first, let's describe stem cells; examine the many possible goods that stem cells offer; list the sources of stem cells; and examine the ethical issues in stem cell use.
Stem cells are marvelously versatile; they are pluripotent in character. They are unspecialized cells that have the capacity to give rise to many different kinds of cells -- all two hundred of the different types of cells -- nerve cells, muscle cells, cardiac cells, etc. in the human body. Stem cells are present in the blood stream, in bone marrow, in the umbilical cord, in fetal tissue, in certain types of tumors, and in the inner cell mass of the embryo. Stem cells are considered potentially immortal, that is, they have indefinitely continuous divisional ability without the loss of genetic structure. The potential limitless diversity and the potential immortality of stem cells make them very valuable, indeed. It has been suggested that stem cells might be able to generate new nerve cells and, hence, might be the source of a cure for spinal cord injuries, or that stem cells might replace impaired or disrupted or damaged brain cells and, hence, are a potential cure for Parkinson's Disease or for Alzheimer's Disease. It has been suggested that stem cells as a source of heart tissue or other solid organ tissue might make it possible to bypass the problem of organ rejection common in transplantation procedures. And it has been suggested that the study of early human development by using the embryo generated in somatic cell nuclear transfer, might be the key to preventing development damage for future desired children.
Use of stem cells found in the blood stream, in bone marrow, in the umbilical cord, in some fetal tissue, and in certain types of tumor is unproblematic. A straightforward application of the principle of totality suffices -- the part may be used for the good of the whole. The problem with the use of stem cells taken from the inner cell mass of the embryo prior to implantation is that the embryo is destroyed in the harvesting of the stem cells. If the embryo is a living developing human being, then its life may not be destroyed to heal illnesses of other presently living developing human beings and its life may not be destroyed to serve the good of developmental correction for future living developing human beings. The rules governing the principle of totality in an organism that is a moral community apply here. Most significant here is that only the activities and not the life of the part (of the embryo) may be used for the good of the whole (the person who would receive the stem cells or the society that would benefit from the research).
The status, then, of the preimplatation embryo, the embryo produced by the procedure of somatic cell nuclear transfer is a critical issue. In contemporary medical ethics, there are different claims about the status of the preimplantation embryo. Significant among them are the following: (1) the preimplantation embryo is just a set of cells organized now in a particular manner; it is permissible to organize them in another manner so long as the reorganization serves a human good; (2) the preimplantation embryo is the earliest stage of development in human life; it deserves profound respect, but not the respect owed to more developed forms of human life; and (3) the preimplantation embryo is the earliest stage of development of human life and deserves the same respect accorded to all other living developing human beings. The answer to this question of the status of the preimplantation embryo has been answered with much care in the lecture on abortion. The conclusion presented there is: a human being is an open unfinished being who begins existence at syngamy and becomes what it is by developing its potentialities. The becoming which is described in various stages, is a time conditioned unfolding of the possibilities given at syngamy. It is then a member of the moral community. Its life may not be directly taken to satisfy some human good other than life.
Nonetheless, a brief response to the particular opposing perspectives is appropriate. Those who defend the first sometimes make the claim that the embryo produced by somatic cell nuclear transfer is an artifact -- just a piece of tissue -- and is different from the embryo produced by sexual reproduction. Now while it is true that the method of its coming into existence is different, it is still an embryo and as an embryo it is different from other types of tissue which remain, through out the life of the tissue, simply that type of tissue. The embryo is a living developing human being who, by its active natural potentiality, is destined to become a more fully developed human being.
Those who defend the second position seem on face value to have the least defensible position. They recognize the embryo as an early stage in the life of an individual and require "profound" respect for that life, but allow the direct destruction of that life to serve the health or well-being of some other human being. There is something incompatible with the claim to proffer profound respect in an act which countenances the killing of the object of the profound respect.
In summary both cloning-to-produce-children and cloning-for-biomedical-research, even if technically possible, are morally impermissible.